WO2023102609A1 - Dispositif de fixation osseuse - Google Patents

Dispositif de fixation osseuse Download PDF

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Publication number
WO2023102609A1
WO2023102609A1 PCT/AU2022/051474 AU2022051474W WO2023102609A1 WO 2023102609 A1 WO2023102609 A1 WO 2023102609A1 AU 2022051474 W AU2022051474 W AU 2022051474W WO 2023102609 A1 WO2023102609 A1 WO 2023102609A1
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WO
WIPO (PCT)
Prior art keywords
bone
band
tensioning
plate
fixation device
Prior art date
Application number
PCT/AU2022/051474
Other languages
English (en)
Inventor
Alistair George Royse
Colin Forbes ROYSE
Original Assignee
Innovate Surgical Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2021903982A external-priority patent/AU2021903982A0/en
Application filed by Innovate Surgical Pty Ltd filed Critical Innovate Surgical Pty Ltd
Publication of WO2023102609A1 publication Critical patent/WO2023102609A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • A61B17/823—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage for the sternum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A61B17/8076—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for the ribs or the sternum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/809—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with bone-penetrating elements, e.g. blades or prongs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/842—Flexible wires, bands or straps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8869—Tensioning devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B2017/564—Methods for bone or joint treatment

Definitions

  • the present invention relates to the field of medical surgery and to the fixation of bones in order to facilitate repair.
  • a further object of the present invention is to alleviate at least one disadvantage associated with the related art.
  • a fixation device comprising: a plate; a tensioning band having a first end associated with, preferably substantially fixed, to the plate; and a tensioning block mounted to the plate, wherein a second end of the tensioning band is passed through the tensioning block in use.
  • the tensioning block comprises a band entry port, a band exit port, a roof located therebetween, and a roller located beneath the roof.
  • the roof of the tensioning block comprises a retention flange and an angled section, and wherein the roller is maintained within the tensioner block between the retention flange and the roof.
  • the plate comprises bone engagement members.
  • a method of clamping a bone using the bone fixation device comprising a plate comprising bone engagement members, a tensioning band and a tensioning block, the method comprising:
  • Figure 1 illustrates a prior art bone fixation device.
  • A the device prior to installation;
  • B devices in use on a sternum; and
  • C illustration of tensioning device.
  • Figure 2 is a top perspective view of a bone fixation device according to an embodiment of the present invention.
  • Figure 3 is bottom perspective view of the device illustrated in Figure 2.
  • Figure 4 is a lateral cross-sectional view of the plate and tensioning block of the device illustrated in Figure 2.
  • Figure 5 is a medial cross-sectional view of the plate and tensioning block of the device illustrated in Figure 2.
  • Figure 6 shows various views of a device according to an embodiment of the present invention, incorporating a crimp on the second end of the tensioning band.
  • Figure 7 shows various views of a device according to an embodiment of the present invention, incorporating a crimp for fixing the second end of the tensioning band to a position near the first end of the tensioning band.
  • Figure 8 shows various views of a device according to an embodiment of the present invention, incorporating a crimp co-formed with the plate.
  • Figure 9 is a perspective view of a bone fixation device according to an embodiment of the present invention, comprising connecting bars according to an embodiment of the present invention.
  • Figure 10 is a medial view of the device illustrated in Figure 9.
  • Figure 1 1 shows perspective views of a bone fixation device according to an embodiment of the present invention, comprising a connecting panel according to an embodiment of the present invention.
  • Figure 12 shows perspective views of a bone fixation device according to an embodiment of the present invention, comprising a connecting panel according to a further embodiment of the present invention.
  • inventive device [0018] The inventors have performed a randomised controlled study into the use of the inventive device and compared it to conventional wire cerclage. They found that the inventive device had superior healing. The implication of this finding is that the inventive device provides better stabilization of the fracture than the conventional wire treatment.
  • Prior art devices typically involve the use of conventional orthopaedic plate technology which comprises a device that spans the fracture and is fixed to both sides of the fracture by the use of screws.
  • a more recent development has been the addition of a band system to wrap around the fractured bone to provide additional support.
  • the use of a band spreads forces across a larger surface area of the bone than that achievable with conventional stainless-steel wires.
  • the SternaLock360 device (see Figure 1 A) is a currently available device which is designed for use in supporting the sternum during fracture repair.
  • This device uses an orthopaedic plate 10 in combination with a band 20.
  • the combination of plate 10 and band 20 is used on the sternum because the forces acting on the sternum during normal activities are substantially greater than those encountered in other typically fractured bones, such as the arm or leg. Further, simply breathing results in movement of the ribs and sternum. It is clear that standard technologies are insufficient to immobilize the chest during fracture healing. For example, one patient coughed so hard that the titanium band surrounding the sternum snapped completely.
  • the plate 10 and band 20 of the SternaLock360 are used to appose the left 32 and the right 33 halves of the sternum. It is further shown that the Sternalock360 uses screws 15 to attach the plate 10 to the bone.
  • the principle of orthopaedic screw length measurement is that the screw should pass through the first thick cortical layer of bone, then through the soft marrow and then to engage (but not pass through) the deeper cortical bone. In this way, the sharp tip of the screw does not injure any structure underlying the bone.
  • the SternaLock360 also requires the use of a specialized tensioning device 40 with a screw thread to provide tension on the band bringing the two edges of the bone together, and then there are screws 15 placed through the plate 20 to hold the plate in place across the fracture line 34 in the sternum.
  • Another key consideration for closing the sternum is how does one get back into the chest in a very rapid fashion under emergency circumstances on some select rare occasions. This would include, for example, when there is a blood clot around the heart compressing the heart.
  • a SternaLock360 device When a SternaLock360 device has been used, the surgeon requires a heavy-duty metal cutter to divide the band 20 and the plates 10. While this a rare event, it is particularly difficult but must be performed without delay.
  • the device of the present invention seeks to provide an improved bone fixation device suitable for sternal fixation. While the present invention is described herein with specific reference to sternal fixation, the principles described are readily adaptable for use in relation to additional bone fractures. These additional applications are intended to be encompassed by the present description.
  • the invention described herein is a major simplification of the technology (and technique) required to internally fixate the sternum (breastbone) following cardiac surgery.
  • the technology simplifies both the manufacturing process leading to cheaper production, as well as to simplification of the technique of insertion leading to improved surgeon acceptance.
  • the present invention provides a bone fixation device comprising a plate; a tensioning band, having a first end and a second end; and a tensioning block attached to or co-formed with, the plate.
  • the first end of the tensioning band is immobilized at or adjacent to the plate and/or tensioning block.
  • the second end of the tensioning band is adapted to be received through a band entry port into the tensioning block.
  • the tensioning block includes a mechanism which allows only unidirectional movement of the tensioning band through the tensioning block. Specifically, the second end of the band may only pass through the tensioning block in a single direction, this allows the band to be pulled tight and to essentially remain at a specific location, whereby tension on the tensioning band is maintained.
  • the tensioning band is passed around the fractured bone and inserted into the band entry port of the tensioning block, through the tensioning block and out a band exit port.
  • the tensioning band is then pulled tight whereby the tensioning band is brought to bear upon the outer surfaces of the fractured bone and the edges of the fractured bone are thereby brought into contact.
  • the tightening of the tensioning band the plate is brought into close contact with the fractured bone.
  • the plate further comprises substantially circular openings adapted to receive screws whereby the plate may be fixed to the fractured bone by way of screws, in a manner analogous to that illustrated in Figure 1 B.
  • the plate further comprises bone engagement members.
  • the bone engagement members bear against, and preferably pierce, the bone, thereby fixing the fractured bone in the position in which it is to repair.
  • a supplementary band restraint may be incorporated into the device, either as a separate component or co-formed therewith.
  • the supplementary band restraint may be employed to maintain a greater tension in the tensioning band than would be possible in the absence of the supplementary band restraint.
  • the supplementary band restraint is in the form of a crimp applied to the tensioning band. More preferably, the supplementary band restraint is situated around the tensioning band to prevent the second end of the tensioning band being able to pass, backwards, through the band exit port.
  • a bone fixation device 100 of the present invention comprises a plate 110, a tensioning band 120 and a tensioning block 130.
  • the tensioning band 120 is fixed at or near its first end 121 to the plate 1 10 and/or tensioning block 130.
  • the free, second end of the tensioning band is passed around the sternum, or through the manubrium, then back into the tensioning block 130. Once the two halves of the sternum are aligned, the tensioning band 120 is pulled through the tensioning block 130.
  • the tightening of the tensioning band 120 assists in bringing the two halves of the sternum together.
  • bone engagement members 11 1 of the plate 1 10 are forced into the underlying bone.
  • the bone engagement members 1 1 1 essentially fix the plate to the underlying bone and thereby eliminates the need for screws to fix the plate 110 relative to the bone.
  • the plate 1 10 of the inventive device performs a similar function to that of previous devices in that it is intended to span the bone fracture, engage the bone whereby the bone is fixed in position for healing or repair. Unlike previous devices, the plate 1 10 of the inventive device is not screwed to the bone. Engagement with the fractured bone is preferably achieved through bone engagement members 1 1 1 which are preferably coformed with the plate 1 10. In the illustrated embodiment, the bone engagement members 1 1 1 are in the form of pointed projections, or teeth.
  • the bone engagement members may be forcibly engaged to the bone prior to the tightening of the tensioning band 120, for example, by pushing the plate 1 10 against the bone, or through the use of a hammer or mallet.
  • the tightening of the tensioning band 120 may force the bone engagement members into the bone.
  • the tensioning band 120 comprises a first end 121 and a second end 122.
  • the tensioning band is preferably a substantially flexible, flat band having a narrow rectangular cross-section.
  • the first end 121 of the tensioning band must be securely fixed to or adjacent to the plate 1 10 and/or tensioning block 130.
  • the first end 121 is looped around a portion of the tensioning block 130, which is attached to the plate 1 10.
  • the first end 121 may comprise a thickened or tapered portion.
  • the second end 122 band may be passed through an opening in the plate 1 10 or tensioning block 130 that will only permit passage of the nonthickened portion of the tensioning band. Accordingly, when the tensioning band 120 is pulled further, the first end 121 will engage firmly with the plate 1 10 or tensioning block 130.
  • This alternative embodiment may be suitable for use when the plate 1 10 is engaged with the bone prior to tightening of the tensioning band 120, as discussed above.
  • the tensioning band 120 is adapted to be passed around the fractured bone and back to the plate 110 and/or tensioning block 130.
  • the band may be passed through the manubrium (upper part of the sternum).
  • a plurality of fixation devices would be used to fix the sternum, for example, one through the manubrium, and two or three around the body of the sternum.
  • the fracture would run at right angles to the tensioning band, and the plate would straddle the fracture.
  • the bone engagement members of the plate would pass into (or even through) the superficial cortex layer of the sternum and provide rigid fixation of the plate to the bone.
  • the tensioning block 130 comprises a band entry port 131 , a band exit port 132; a roof 133; a retention flange 134; and a roller 135.
  • the band entry port is adapted to receive a second end 122 of the tensioning band 120.
  • the tensioning band 120 is then threaded through the tensioning block 130 and exits the tensioning block 130 via a band exit port 132.
  • a roof 133 Between the band entry port 131 and the band exit port 132 is located a roof
  • the roof 133 is angled or curved, substantially as illustrated in Figure 4, whereby the roof 133 begins near the band entry port 131 and rises to an apex where the retention flange 134 begins.
  • the roller 135 is an extension of the roof 133 that is bent downwards towards the band exit port 132. Located beneath the roof 133 is a roller 135, preferably the roller 135 is in the form of a roughened ball.
  • the roof 133 and retention flange 134 are sized and positioned whereby the roller 135 is loose but retained within the tensioning block 130, beneath the roof 133.
  • the roller 135 is located between the roof 135 and the tensioning band 120.
  • the roller 135 is caused to move towards the retention flange 134, at which position, the roller 135 is free to rotate and the tensioning band 120 is able to move through the tensioning block 130.
  • the tensioning band 120 When the tensioning band 120 is released, it moves in the opposite direction.
  • the roughened surface of the roller 135 allows it to be gripped by the tensioning band 120, thereby moving the roller towards the band entry port 131 .
  • Due to the slope of the roof 133 movement of the roller 133 towards the band entry port 131 is restricted and the roller 133 becomes wedged between the tensioning band 120 and the roof 133.
  • the roller 133 As the roller 133 is moved closer to the band entry port 131 , the roller 133 becomes more tightly wedged between the tensioning band 120 and the roof 133, thereby preventing further movement of the tensioning band 120 and locking it in place.
  • Figure 3 illustrates the depth of the bone engagement members 11 1 from the plate 110. It will be apparent to the skilled person how the bone engagement members 1 1 1 are intended to penetrate the cortex of the bone when force is applied. As noted above, a small hammer can be used to further apply downward pressure on the plate 1 10 to assist with penetration of the bone engagement members 1 1 1 into the bone.
  • FIG 4 is a cross-sectional view of an embodiment of the tensioning block 130 according to an embodiment of the present invention.
  • the tensioning block 130 contains a roughened roller 133 which acts as a one-way valve in that when the tensioning band 120 is passed through the tensioning block, the tension force is retained, and the redundant length of the band may then be cut short.
  • the first end 121 of the tensioning band 120 is retained firmly by the tensioning block 130.
  • the first end 121 may be folded over a portion of the plate 1 10 or tensioning block 130 wherein tensioning of the tensioning band 120 causes the first end 121 to be held securely against the plate 1 10 or tensioning block 130.
  • an advantage over previous devices is that the present inventive device may be readily removed in an emergency.
  • an emergency re-entry occurs within hours to a couple of days after surgery, whereby there is no solid new bone formation as yet.
  • the patient is about to arrest or has arrested, and the circumstances are extremely dire, and urgency is substantial.
  • the present device would be easily removed if required by simply lifting up the band to the side of the plate and dividing the band with a metal cutter. Thereafter, the entire device would simply be removed from the chest with a single forceful traction on the plate itself. This would be considerably superior to the existing devices, which require screws to be removed, and even to the conventional wire cerclage technique.
  • the presently described band and plate system could provide for all of the stability of standard plating engagement with the bone by way of the sharp projections passing into the bone cortex itself, as well as all of the compression force being applied to the two halves of the sternum, and that force being retained.
  • Figures 6A and 6B show views of an embodiment of the present invention which incorporates a supplementary restraint in the form of a deformable crimp 136 located on the second end 122 of the tensioning band, ie the part that protrudes from the band exit port 132.
  • the crimp 136 is a metal component that is positioned around the band 120.
  • a gap in the crimp 136 allows for easy manipulation and installation adjacent the second end 122 of the band, after deployment of the tensioning band 120 and preliminary tensioning using the tensioning block 130 mechanism.
  • a laterally directed force on both sides of the crimp 136 may be applied bringing the central portion of the crimp 136 closer together to fix it to the tensioning band 120 and thus deforming the crimp to form a "waist" which would then permanently retain that applied force.
  • this embodiment could employ a continuous crimp (not illustrated), since the tensioning band 120 could be cut to length before slipping the crimp on the second end 122 of the tensioning band.
  • Figure 6B illustrates the position of the crimp 136 and its position adjacent to the plate 1 10. Once fixed in place adjacent the second end 122 of the tensioning band, the crimp 136 would prevent the tensioning band 120 being drawn back through the band exit port 132 in the event of a failure of the tensioning block 130 and roller 135 to securely restrict movement of the tensioning band 120.
  • Figure 7 shows views of embodiments of the present invention that incorporate a supplementary restraint in the form of a deformable crimp 136 positioned to fix the second end 122 of the tensioning band to a portion of the tensioning band 120 close to its first end 121 , whereby a continuous loop of tensioning band is formed (i.e. effectively joins the first end 121 and second end 122).
  • the crimp 136 may include a gap 137 to allow easy manipulation after an initial deployment and tensioning of the tensioning band 120.
  • Figures 7A and 7B show the gap 137 being superficial (i.e. away from the bone surface). This embodiment necessitates manipulation from the bone-side of the band prior to significant tensioning occurring. This may provide an advantage of being able to easily remain in position as the tensioned band 120 would press this crimp 136 against the bone.
  • FIG. 7C and 7D like the embodiment illustrated in Figures 7A and 7B, illustrates a supplementary restraint that involves a crimp 136 that is employed to form a loop of tensioning band.
  • the gap 137 in the crimp 136 is illustrated facing the bone surface.
  • the crimp 136 could be applied after initial tensioning of the band 120 with the initial approximation of the bone edges, as retained initially by block 130.
  • the crimp 136 By minor adjustment to the crimp 136, it can be manoeuvred into position, which would then allow for further tensioning of the band 120, downward pressure on the continuous part of the crimp 136 against the bone to stop it from dislodging, and subsequent crimping to retain the position.
  • Figure 8 illustrates a further embodiment of a device comprising a supplementary restraint. As illustrated, a crimp 136 is co-formed and continuous with the plate 110, rather than being present as a separate component. This embodiment of the invention operates in a manner similar to the embodiment illustrated in Figures 7C and 7D.
  • connecting bars 140 could be used for connecting bars 140, as illustrated in Figures 9 and 10.
  • the plates at the upper end of the sternum will allow for retardation of movement at the lower end of the sternum due to the redistribution of lateral force along the length of the connecting bars 140.
  • the rigid joining of a device at each end of the sternum provides rigidity along the full length of the sternum.
  • the devices therefore act as a single unit rather than each individual band and plate acting in isolation to redistribute a distracting force from a first plate to second, adjacent, plate.
  • the connecting bars 140 may be locked in position by teeth 141 that interlock with the bone engagement members 11 1 .
  • the connecting bars 140 do not have teeth.
  • the connecting bars 140 may engage a flange 142 on the plate 1 10 (for example see Figures 6 to 8), in an insertable fashion which would allow for some repositioning of the plates 1 10 during deployment, but later having sufficient grip on the plate 1 10, via the flange 142, to allow full redistribution of lateral forces between plates 1 10.
  • the number of teeth on the side of plate 110 are reduced to affect the use of a wider bar which then engages with end and central teeth as in Figure 6A, 6B.
  • the band in this instance is passed around the rib on one side of the fracture, and then is passed through the tensioning block, and tensioned.
  • the bone engagement members of the plate will then further add to stability by passing into the bone of the rib.
  • the same process is then applied to the rib on the other side of the fracture.
  • ribs are smaller than the sternum, a range of plate sizes is available so that a selection appropriate to the patient could be made.
  • the two rib ends are mobilised and reduced so that they now align correctly, and the intended sites for encirclement of the rib on either side of the fracture is identified, then a measurement is made of the distance between these two points, and an appropriate length of plate selected from a range of sizes available.
  • Appropriately sized and curved connecting bars are also employed to provide support for the correct curvature of the ribs across the fracture site and to assist with the distribution of forces exerted in a novel manner.
  • the connecting bars can be used in respect of fractures of the sternum and ribs.
  • the band and block/plate device in isolation without the connecting bar which runs parallel to the long axis of the sternum (thereby relying on the hemi-sternum to provide strength between these devices), i.e. the devices are not deployed on either side of the fracture.
  • the band “cuts through” the bone not uncommon
  • each side of the sternum is now effectively fractured in the short axis of the sternum in addition to the long axis.
  • the use of connecting bars would act to distribute this lateral distracting force across the whole of the sternum rather than just in one site (greatest at the lower end).
  • Connecting bars may have other uses.
  • the two bands/blocks would be installed on either side of the fracture.
  • having a rigid connecting bar between the two bands/blocks is necessary in order to bridge the fracture and connect the two bands and blocks together rigidly, i.e. it acts as the “plate” used in contemporary devices, crossing from one side of the fracture to the other.
  • the “bar” is present on one side of the bone only, and logically the strength of the bar would be greater in one direction (force directed towards the bar) than in the opposite direction (force directed away from the bar).
  • the skilled person could deploy two band/block and bar devices - on both sides of a fractured bone (or even more than two). Take for example, fixation of a rib, clavicle or humerus, if two devices of the present invention, on diametrically opposite sides of the bone (180 degrees apart), then there would be bars present on both sides of the bone and this would result in considerably greater strength.
  • the present invention also encompasses a bone fixation system comprising: a first fixation device; and a second fixation device; and a connector bar linking the first and second fixation devices.
  • the bone fixation system may be employed in a method of clamping a bone, the method comprising the steps of:
  • each tensioning band is held in place by a roller located within a respective tensioning block.
  • the above method of using the bone fixation system may further comprise the step of fixing a supplementary restraint adjacent to the second end of each tensioning band.
  • bones that are most suitable for devices of the present invention include the sternum and cylindrical bones such as larger/longer bones - femur, tibia, fibula, humerus, radius, ulna; smaller/shorter bones - hands/feet: metacarpals, phalanges (fingers/toes); ribs; and clavicle (collar bone).
  • the connecting bars seek to maintain rigid orientation of the plates for forces of all vectors thereby maintaining the relative position of the adjacent bone edges at all times irrespective of the nature or direction of forces applied.
  • the mechanism of this aspect of the present invention allows blocks to be rigidly fixed on either side of a fracture by the band and plate/block mechanism being a combination of encirclement and direct engagement of the cortical bone and a connecting bar of metal to then rigidly fix these two blocks together which crosses from one side of the fracture to the other.
  • an elongated plate 150 may be employed, wherein the elongated plate 150 comprises tensioning blocks 130, and associated tensioning bands 120, adjacent each end of the elongated plate 150.
  • Two exemplary embodiments of such a device are shown herein. It will be apparent to the skilled person, that these embodiments may be used in similar situations to a device comprising one or more connecting bars.
  • the device may be installed wherein a bone fracture is located between the tensioning bands 120, and the elongated plate 150 prevents or at least severely restricts relative movement of the fractured bone during healing.
  • the device illustrated in Figure 12 includes an opening 151 in the elongated plate 150.
  • the opening 151 may allow examination of the underlying fracture and/or bone during healing.
  • ultrasound may be used to image the underlying fracture and/or bone through the opening 151.
  • examination of the underlying fracture and/or bone would be difficult.
  • the device of the present invention has been described and illustrated in a manner that implies only encircling of bones by the tensioning band(s) 120.
  • the tensioning band 120 must be passed through a bone in order to avoid other internal structures such as connected bones, or to provide a stronger installation.
  • the tensioning band 120 may include at its second end 122 a needle for passing through a bone.
  • the needle may be removed prior to the second end 122 being received in the band entry port 131 .
  • the bone fixation devices of the present invention are made of titanium, titanium alloys or medical grade stainless steel.
  • means-plus- function clauses are intended to cover structures as performing the defined function and not only structural equivalents, but also equivalent structures.
  • a nail and a screw may not be structural equivalents in that a nail employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical surface to secure wooden parts together, in the environment of fastening wooden parts, a nail and a screw are equivalent structures.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

La présente invention concerne un dispositif de fixation osseuse comprenant : une plaque ; une bande de tension ayant une première extrémité sensiblement fixée à la plaque ; et un bloc de tension monté sur la plaque, une seconde extrémité de la bande de tension étant passée à travers le bloc de tension, lors de l'utilisation. Le dispositif de fixation osseuse de la présente invention peut être adapté pour être fixé à un os qui nécessite une fixation pour permettre la réparation.
PCT/AU2022/051474 2021-12-09 2022-12-08 Dispositif de fixation osseuse WO2023102609A1 (fr)

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AU2021903982A AU2021903982A0 (en) 2021-12-09 Bone fixation device
AU2021903982 2021-12-09

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WO2023102609A1 true WO2023102609A1 (fr) 2023-06-15

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5356417A (en) * 1992-10-09 1994-10-18 United States Surgical Corporation Absorbable sternum closure buckle
US5356412A (en) * 1992-10-09 1994-10-18 United States Surgical Corporation Sternum buckle with rotational engagement and method of closure
US20120041441A1 (en) * 2010-08-10 2012-02-16 Acute Innovations, Llc. Cable tie system for stabilizing bone
US20140309699A1 (en) * 2013-02-07 2014-10-16 Louis Houff Sternum fixation device and method
US20190374268A1 (en) * 2015-03-25 2019-12-12 Coracoid Solutions, Llc Joint repair system
WO2020036557A2 (fr) * 2018-05-04 2020-02-20 Kabalci Mehmet Suture à caractéristique élasto-plastique et système de stabilisation

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5356417A (en) * 1992-10-09 1994-10-18 United States Surgical Corporation Absorbable sternum closure buckle
US5356412A (en) * 1992-10-09 1994-10-18 United States Surgical Corporation Sternum buckle with rotational engagement and method of closure
US20120041441A1 (en) * 2010-08-10 2012-02-16 Acute Innovations, Llc. Cable tie system for stabilizing bone
US20140309699A1 (en) * 2013-02-07 2014-10-16 Louis Houff Sternum fixation device and method
US20190374268A1 (en) * 2015-03-25 2019-12-12 Coracoid Solutions, Llc Joint repair system
WO2020036557A2 (fr) * 2018-05-04 2020-02-20 Kabalci Mehmet Suture à caractéristique élasto-plastique et système de stabilisation

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